Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000677101
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
6/05/2019
Date last updated
7/07/2020
Date data sharing statement initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Active Breed randomised controlled trial: A weight loss and lifestyle modification program for male football fans in South-Western Sydney
Scientific title
The Active Breed randomised-controlled trial: A gender-tailored weight loss and lifestyle modification program for overweight male football fans in South-Western Sydney
Secondary ID [1] 298073 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
A pilot study testing the feasibility and preliminary efficacy of the Active Breed program (ACTRN12618000740291) has been conducted. The current study is a fully-powered randomised controlled trial.

Health condition
Health condition(s) or problem(s) studied:
Obesity 312573 0
Physical inactivity 312574 0
Dietary intake 312575 0
Mental health 312576 0
Domestic and family violence 312577 0
Depression 312665 0
Condition category
Condition code
Public Health 311087 311087 0 0
Health promotion/education
Diet and Nutrition 311088 311088 0 0
Obesity
Mental Health 311089 311089 0 0
Depression
Physical Medicine / Rehabilitation 311090 311090 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active Breed is a 12-week men's health intervention targeting:
- weight loss through sustainable healthy lifestyle behaviours
- physical activity, including goal setting, strategies to increase physical activity and overcoming barriers
- nutrition, including increasing fruit and vegetable consumption, reducing saturated fat, salt, sugar and processed food intake
- mental health, including depression and anxiety and practical strategies to deal with stress
- domestic and family violence prevention, including recognising signs of abuse and violence

The intervention will be tested as a two-armed randomised controlled trial, with a wait-list control group who will receive the intervention at a later date.

Group-based (face-to-face) sessions will be held once per week for 12 weeks at Belmore Sports Ground (Canterbury-Bankstown Bulldogs' home stadium). Each weekly session will run for 90 minutes and will comprise an educational component (45-60 minutes) and a physical activity component (30-45 minutes). These sessions will be delivered by trained Active Breed facilitators, with support from content area experts including qualified exercise scientists and personal trainers (physical activity), mental health support services (representative from an organisation such as the South Western Sydney Primary Health Network), and domestic and family violence experts (representatives from White Ribbon Australia).

Active Breed facilitators will have expertise in physical activity (e.g., PhD qualified in health and physical activity promotion, qualified exercise scientists). The physical activity facilitators for this trial completed relevant training prior to the delivery of the pilot RCT (ANZCTRN12618000740291) and delivered the physical activity sessions in the pilot RCT. These facilitators will attend a brief training session prior to delivery of this trial, with at least one senior member (PhD qualified) of the research team, to revisit strategies to engage men, build rapport and promote healthy lifestyle messages. Any new facilitators or guest presenters for this trial will be debriefed by a senior member of the research team before delivering an education session to ensure educational content is gender appropriate and engaging.

At least one member of the research team will be in attendance at all sessions, and facilitators will be involved in a debriefing session with the researcher/s after each session and at the end of the 12-week program to identify strengths and areas for improvement.

One topic will be covered in each educational session, and these topics will be scheduled prior. The content delivery will vary in each session, and activities will include brief, interactive presentations and demonstrations (e.g., cooking class) and group discussion activities.

The weekly physical activity component of the sessions will include low to moderate intensity football skills and drills (intensity based on Borg RPE), small-sided touch football games, and supervised gym sessions. All physical activity sessions will be delivered by a qualified exercise scientist.

All participants will be provided with program resources including an Active Breed player manual, generic information about health and health services (readily available, to be
provided by external facilitators from external stakeholders), equipment pack (including a training shirt, towel, drink bottle and backpack), and exclusive access to a participant website where program materials will be made available outside regular weekly sessions.

Participants will be encouraged to engage with the website at least weekly to support healthy lifestyle behaviours beyond the scope of the weekly sessions. Each intervention participant will receive a unique login allowing exclusive access to the website.

Adherence to the intervention will be monitored by attendance records at the weekly sessions, and a post-program evaluation exploring the importance of topics and quality of program elements will be completed by all participants at the end of the 12-week program.
Intervention code [1] 314304 0
Lifestyle
Intervention code [2] 314355 0
Behaviour
Comparator / control treatment
The wait-list control group will be offered the intervention after the 24-week assessment period for intervention participants.
Control group
Active

Outcomes
Primary outcome [1] 319870 0
Weight - to be measured using calibrated electronic scales
Timepoint [1] 319870 0
Baseline, week 12 (end of intervention - primary end point) and 24 weeks post-enrolment.
Secondary outcome [1] 369751 0
Body Mass Index (BMI) - to be calculated from participant height (measured using a stadiometer) and weight (measured using calibrated electronic scales). BMI will be calculated as weight in kilograms, divided by the square of height in metres.
Timepoint [1] 369751 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [2] 369752 0
Waist circumference - measured using a non-elastic tape measure at the midpoint between the lowest rib and the iliac crest.
Timepoint [2] 369752 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [3] 369753 0
Light physical activity - total minutes and percentage of time, to be measured using ActiGraph GT3X accelerometers.
Timepoint [3] 369753 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [4] 369797 0
Moderate-to-vigorous physical activity - total minutes and percentage of time, assessed using ActiGraph GT3X accelerometers.
Timepoint [4] 369797 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [5] 369801 0
Step counts (daily and weekly) - to be assessed using ActiGraph GT3X accelerometers.
Timepoint [5] 369801 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [6] 369803 0
Dietary intake - assessed using Food Frequency Questionnaire
Timepoint [6] 369803 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [7] 369804 0
Blood pressure - measured using a digital upper-arm blood pressure monitor - three measurements to be
taken and averaged for an accurate reading.
Timepoint [7] 369804 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [8] 369805 0
Symptoms of depression and anxiety - measured using the Kessler-10 psychological distress scale.
Timepoint [8] 369805 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [9] 369806 0
Health-related quality of life - measured using a single-item question: In general, how would you rate your health-related quality of life?
Timepoint [9] 369806 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [10] 369807 0
Health literacy - measured using the Health Literacy Questionnaire
Timepoint [10] 369807 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [11] 369808 0
Perceptions of gender equality - measured using the Gender Equality Attitude Scale.
Timepoint [11] 369808 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [12] 369809 0
Perceptions of domestic and family violence - measured using the National Attitudes Towards Violence Against Women Survey tool (specifically, modules 1, 2 and 4).
Timepoint [12] 369809 0
Baseline, week 12 (end of intervention) and 24 weeks post-enrolment.
Secondary outcome [13] 369810 0
Perceptions of the Active Breed program - Participants will be asked to complete a process evaluation questionnaire (designed specifically for this study) to identity strengths and weaknesses of the intervention, perceptions of the importance and applicability of content and suggestions related to the delivery of the intervention.
Timepoint [13] 369810 0
Week 12 (end of intervention) only.

Eligibility
Key inclusion criteria
- Are male
- Are aged between 35 and 64 years
- Have a BMI of 25kg/m2 or higher
- Pass a pre-exercise screenin g questionnaire (or obtain a letter of clearance from their doctor if shown to be at high-risk of exercise-related contraindications).
- Can attend group-based sessions at Belmore Sports Ground.
Minimum age
35 Years
Maximum age
64 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men will not be eligible to participate if they:
- Do not pass the pre-exercise screening assessment (indicating they are at high risk of contraindications associated with physical activity) or obtain a letter of clearance from their doctor.
- Cannot attend group-based sessions at Belmore Sports Ground
- Have recently participated in or are intending to participate in another weight loss intervention or program concurrently.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be required to complete a pre-exercise screening assessment prior to participating in the study. Once cleared, participants will be randomly allocated to the intervention or wait-list control group.

The random allocation sequence will be generated by a statistician. Study information for the intervention and wait-list control groups will be placed into opaque envelopes and consecutively numbered according to the randomisation schedule. This process will be completed by a research assistant who is not involved in enrolment, assessment or allocation of participants.

Upon completion of baseline measurements, participants will meet with a research assistant (not involved in collecting outcome data) in a separate room to open the allocation envelope. The research assistant will explain the allocation based on the information contained in the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation allocation sequence will be generated by a statistician who will not have any contact with participants during the trial. The statistician will generate a randomisation table created by computer software (i.e. computerised sequence generation). The randomisation allocation sequence will be stored securely and concealed from research assistants involved in data collection, group allocation and data entry.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Generalised linear mixed models will examine differences in primary and secondary outcomes between treatment groups. Qualitative data from the process evaluation will be analysed using hierarchical content analysis to generate meaning units, categories and themes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2019
Actual
29/05/2019
Date of last participant enrolment
Anticipated
17/06/2019
Actual
4/07/2019
Date of last data collection
Anticipated
31/03/2020
Actual
23/01/2020
Sample size
Target
70
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302604 0
Commercial sector/Industry
Name [1] 302604 0
Canterbury League Club Ltd
Country [1] 302604 0
Australia
Funding source category [2] 302626 0
Government body
Name [2] 302626 0
South Western Sydney Primary Health Network
Country [2] 302626 0
Australia
Funding source category [3] 302627 0
University
Name [3] 302627 0
Western Sydney University
Country [3] 302627 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797, Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 302538 0
None
Name [1] 302538 0
Address [1] 302538 0
Country [1] 302538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303239 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 303239 0
Ethics committee country [1] 303239 0
Australia
Date submitted for ethics approval [1] 303239 0
Approval date [1] 303239 0
22/11/2016
Ethics approval number [1] 303239 0
H11914

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92966 0
Dr Emma George
Address 92966 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 92966 0
Australia
Phone 92966 0
+61 247360052
Fax 92966 0
Email 92966 0
[email protected]
Contact person for public queries
Name 92967 0
Emma George
Address 92967 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 92967 0
Australia
Phone 92967 0
+61 247360052
Fax 92967 0
Email 92967 0
[email protected]
Contact person for scientific queries
Name 92968 0
Emma George
Address 92968 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 92968 0
Australia
Phone 92968 0
+61 247360052
Fax 92968 0
Email 92968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.